Abstract
Study Design.: A prospective, multicenter, randomized, two-arm, single-blind, investigational device exemption pivotal study. Objective.: To assess the efficacy and the safety of a polyethylene glycol (PEG) hydrogel spinal sealant (DuraSeal Spinal Sealant) as an adjunct to sutured dural repair compared with standard of care methods (control) to obtain a watertight dural closure in patients undergoing an intentional durotomy during spinal surgery. Summary of Background Data.: If a watertight dural closure is not achieved, cerebrospinal fluid leak with associated complications may occur. The PEG hydrogel spinal sealant is an Food and Drug Administration (FDA)-approved adjunct to sutured dural repair in spine surgery. This synthetic, absorbable hydrogel sealant works in the presence of fluid, conforms to irregular surfaces, and demonstrates strong adherence and compliance to tissue, without interfering with underlying tissue visibility. Methods.: A total of 158 patients were treated at 24 centers after they were randomized on the basis of an approximately 2:1 ratio (sealant:control); 102 received the PEG hydrogel spinal sealant and 56 received standard care. The primary end point was intraoperative watertight closure. Secondary end points included evaluations of postoperative cerebrospinal fluid leak, infection, and wound healing. Results.: Patients treated with the PEG hydrogel spinal sealant had a significantly higher rate of watertight closure than the control (100% vs. 64.3%, P < 0.001). No statistical differences were seen in postoperative cerebrospinal fluid leak, infection, and wound healing. No neurologic deficits were seen attributable to the sealant. Conclusion.: The PEG hydrogel spinal sealant evaluated in this study is safe and effective for providing watertight closure when used as an adjunct to sutured dural repair during spinal surgery. This readily available tool is superior to other standard of care technologies commonly used to achieve intraoperative watertight dural closure.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 1906-1912 |
| Number of pages | 7 |
| Journal | Spine |
| Volume | 36 |
| Issue number | 23 |
| DOIs | |
| State | Published - Nov 1 2011 |
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Keywords
- DuraSeal spinal sealant
- efficacy
- PEG hydrogel sealant
- safety
- watertight dural closure
ASJC Scopus subject areas
- Clinical Neurology
- Orthopedics and Sports Medicine
Cite this
Polyethylene glycol hydrogel spinal sealant (DuraSeal spinal sealant) as an adjunct to sutured dural repair in the spine : Results of a prospective, multicenter, randomized controlled study. / Kim, Kee D; Wright, Neill M.
In: Spine, Vol. 36, No. 23, 01.11.2011, p. 1906-1912.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Polyethylene glycol hydrogel spinal sealant (DuraSeal spinal sealant) as an adjunct to sutured dural repair in the spine
T2 - Results of a prospective, multicenter, randomized controlled study
AU - Kim, Kee D
AU - Wright, Neill M.
PY - 2011/11/1
Y1 - 2011/11/1
N2 - Study Design.: A prospective, multicenter, randomized, two-arm, single-blind, investigational device exemption pivotal study. Objective.: To assess the efficacy and the safety of a polyethylene glycol (PEG) hydrogel spinal sealant (DuraSeal Spinal Sealant) as an adjunct to sutured dural repair compared with standard of care methods (control) to obtain a watertight dural closure in patients undergoing an intentional durotomy during spinal surgery. Summary of Background Data.: If a watertight dural closure is not achieved, cerebrospinal fluid leak with associated complications may occur. The PEG hydrogel spinal sealant is an Food and Drug Administration (FDA)-approved adjunct to sutured dural repair in spine surgery. This synthetic, absorbable hydrogel sealant works in the presence of fluid, conforms to irregular surfaces, and demonstrates strong adherence and compliance to tissue, without interfering with underlying tissue visibility. Methods.: A total of 158 patients were treated at 24 centers after they were randomized on the basis of an approximately 2:1 ratio (sealant:control); 102 received the PEG hydrogel spinal sealant and 56 received standard care. The primary end point was intraoperative watertight closure. Secondary end points included evaluations of postoperative cerebrospinal fluid leak, infection, and wound healing. Results.: Patients treated with the PEG hydrogel spinal sealant had a significantly higher rate of watertight closure than the control (100% vs. 64.3%, P < 0.001). No statistical differences were seen in postoperative cerebrospinal fluid leak, infection, and wound healing. No neurologic deficits were seen attributable to the sealant. Conclusion.: The PEG hydrogel spinal sealant evaluated in this study is safe and effective for providing watertight closure when used as an adjunct to sutured dural repair during spinal surgery. This readily available tool is superior to other standard of care technologies commonly used to achieve intraoperative watertight dural closure.
AB - Study Design.: A prospective, multicenter, randomized, two-arm, single-blind, investigational device exemption pivotal study. Objective.: To assess the efficacy and the safety of a polyethylene glycol (PEG) hydrogel spinal sealant (DuraSeal Spinal Sealant) as an adjunct to sutured dural repair compared with standard of care methods (control) to obtain a watertight dural closure in patients undergoing an intentional durotomy during spinal surgery. Summary of Background Data.: If a watertight dural closure is not achieved, cerebrospinal fluid leak with associated complications may occur. The PEG hydrogel spinal sealant is an Food and Drug Administration (FDA)-approved adjunct to sutured dural repair in spine surgery. This synthetic, absorbable hydrogel sealant works in the presence of fluid, conforms to irregular surfaces, and demonstrates strong adherence and compliance to tissue, without interfering with underlying tissue visibility. Methods.: A total of 158 patients were treated at 24 centers after they were randomized on the basis of an approximately 2:1 ratio (sealant:control); 102 received the PEG hydrogel spinal sealant and 56 received standard care. The primary end point was intraoperative watertight closure. Secondary end points included evaluations of postoperative cerebrospinal fluid leak, infection, and wound healing. Results.: Patients treated with the PEG hydrogel spinal sealant had a significantly higher rate of watertight closure than the control (100% vs. 64.3%, P < 0.001). No statistical differences were seen in postoperative cerebrospinal fluid leak, infection, and wound healing. No neurologic deficits were seen attributable to the sealant. Conclusion.: The PEG hydrogel spinal sealant evaluated in this study is safe and effective for providing watertight closure when used as an adjunct to sutured dural repair during spinal surgery. This readily available tool is superior to other standard of care technologies commonly used to achieve intraoperative watertight dural closure.
KW - DuraSeal spinal sealant
KW - efficacy
KW - PEG hydrogel sealant
KW - safety
KW - watertight dural closure
UR - http://www.scopus.com/inward/record.url?scp=80054961673&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=80054961673&partnerID=8YFLogxK
U2 - 10.1097/BRS.0b013e3181fdb4db
DO - 10.1097/BRS.0b013e3181fdb4db
M3 - Article
VL - 36
SP - 1906
EP - 1912
JO - Spine
JF - Spine
SN - 0362-2436
IS - 23
ER -